Stavudine (11 brand names, 4 dosage forms, 1 route)
Available dosage forms: TABLET, CAPSULE, CAPSULE, EXTENDED RELEASE, FOR SOLUTION.
Routes of administration: ORAL.
Brand Names
- LAMIVUDINE AND STAVUDINE
- LAMIVUDINE, NEVIRAPINE, AND STAVUDINE
- LAMIVUDINE; STAVUDINE
- LAMIVUDINE; STAVUDINE; NEVIRAPINE
- STAVUDINE
- STAVUDINE; LAMIVUDINE
- STAVUDINE; LAMIVUDINE W/NEVIRAPINE
- STAVUDINE; LAMIVUDINE; EFAVIRENZ
- STAVUDINE; LAMIVUDINE; NEVIRAPINE
- ZERIT
- ZERIT XR
Boxed Warning
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including stavudine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk [see Warnings and Precautions (5.1)]. Fatal and nonfatal pancreatitis have occurred during therapy when stavudine was part of a combination regimen that included didanosine in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression [see Warnings and Precautions (5.4)].
Indications and Usage
Stavudine capsules, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV)-1 infection [see Clinical Studies (14)].
Dosage and Administration
The interval between doses of stavudine capsules should be 12 hours. Stavudine capsules may be taken with or without food.
Contraindications
Stavudine capsules are contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation.
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the labeling: lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning and Warnings and Precautions (5.1)] hepatic toxicity [see Warnings and Precautions (5.2)] neurologic symptoms and motor weakness [see Warnings and Precautions (5.3)] pancreatitis [see Boxed Warning and Warnings and Precautions (5.4)] lipoatrophy/lipodystrophy [see Warnings and Precautions (5.5)] When stavudine is used in combination with other agents with similar toxicities, the incidence of adverse reactions may be higher than when stavudine is used alone.
Drug Interactions
Stavudine is unlikely to interact with drugs metabolized by cytochrome P450 isoenzymes. Zidovudine: Zidovudine competitively inhibits the intracellular phosphorylation of stavudine. Therefore, use of zidovudine in combination with stavudine should be avoided. Doxorubicin: In vitro data indicate that the phosphorylation of stavudine is inhibited at relevant concentrations by doxorubicin. The clinical significance of this interaction is unknown; therefore, concomitant use of stavudine with doxorubicin should be undertaken with caution. Ribavirin: In vitro data indicate ribavirin reduces phosphorylation of lamivudine, stavudine and zidovudine. The clinical significance of the interaction with stavudine is unknown; therefore, concomitant use of stavudine with ribavirin should be undertaken with caution. No pharmacokinetic (e.g., plasma concentrations or intracellular triphosphorylated active metabolite concentrations) or pharmacodynamic (e.g., loss of HIV-1/HCV virologic suppression) interaction was observed when ribavirin and lamivudine (n = 18), stavudine (n = 10) or zidovudine (n = 6) were coadministered as part of a multi-drug regimen to HIV-1/HCV co-infected patients [see Warnings and Precautions (5.2)].
Mechanism of Action
Stavudine is an antiviral drug [see Clinical Pharmacology (12.4)].
Overdosage
Experience with adults treated with 12 to 24 times the recommended daily dosage revealed no acute toxicity. Complications of chronic overdosage include peripheral neuropathy and hepatic toxicity. Stavudine can be removed by hemodialysis; the mean ± SD hemodialysis clearance of stavudine is 120 ± 18 mL/min. Whether stavudine is eliminated by peritoneal dialysis has not been studied.